F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow

NCT04528758 | Suspended Early Phase 1 DMC FDA Drug

• 1 other identifier: 201808025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Dosimetry group

  Evaluate both image quality and myocardial blood flow at different imaging time points. Image quality provides higher count Density and high spatial resolution, which makes it easier to see the heart vessels, and myocardial blood flow is measured in mL/g/min. Both measurements will be agregated to arrive at one reported value helps determine the balance of heart disease and in small and large vessels

  1-2 days

Secondary Outcomes (1)

• Stable Heart Patients

  1-2 days

Study Arms (2)

Dosimetry group

EXPERIMENTAL

Patients in the dosimetry group will be imaged with the radio-pharmaceutical Rhodamine 6G at different time points. 0-120, 30-150, 60-180

Drug: Rhodamine 6G

Stable Heart Patients

ACTIVE COMPARATOR

Stable heart patients will be given a rest/stress PET/CT with Rhodamine 6G myocardial perfusion study to determine myocardial blood flow

Drug: Rhodamine 6G

Interventions

Rhodamine 6G DRUG

Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow

Also known as: PET/positron Emission Tomography imaging

Dosimetry group; Stable Heart Patients

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, 21-75 years of age and any race.
• Capable of giving written informed consent.
• "Healthy adult volunteer subject" is someone who is volunteering to undergo imaging procedures and based on screening procedures has no known significant health problems.
• Stable patients with known or suspected coronary artery disease that are scheduled to have or have undergone a clinically indicated conventional rest/stress SPECT MPI and no intervention between SPECT and PET.
• Female subjects must not be pregnant or lactating.

You may not qualify if:

• Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data.
• Have abnormal findings on any screening/baseline procedure, e.g. physical examination, laboratory tests, electrocardiogram that suggest the subject might have a condition that could, in the opinion of the Sponsor-Investigator, affect the subject's response to the radiopharmaceutical or related research procedures.
• Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
• Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
• Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
• Have high blood pressure (\>200/110)
• Have Epilepsy
• Have major kidney or liver problems
• Have current or past history of major medical illness
• Currently using recreational drugs
• Body weight of \> 300 lbs. (weight limit of the PET/CT table)
• Stable Cardiac Disease: Rest/Stress Group only:
• Cardiac patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest.
• Sinus node disease (e.g. SA block) or symptomatic bradycardia, second or third degree atrioventricular (AV) block.
• Pre-existing obstructive lung disease (e.g. asthma) that precludes the safe administration of the pharmacological stressor according to the approved label.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

rhodamine 6G

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Gropler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 27, 2020
• Study Start: October 16, 2018
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

US (1)